FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAST BRWM, FRACTURE
K Number: K770900
·
Decision Jul 21, 1977
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
4
Applicant Total
10
Review Days
66
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Basic Information
- Device Name
- CAST BRWM, FRACTURE
- K Number
- K770900
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Chase Mfg. Co.
- Date Received
- May 16, 1977
- Decision Date
- July 21, 1977
- Product Code
- ITM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITM | Cage, Knee | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITM), ordered by most recent decision date.
EXTENSION CONTROL KNEE ORTHOSIS
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FDA Class 1
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POLI-AXIAL KNEE CAGE
FDA 510(k)
FDA Class 1
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FRACTURE CAST BRACE, POLY
FDA 510(k)
FDA Class 1
·Physical Medicine
IMPROVED KNEE DRESSING
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Chase Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K791513 | ADAMCO DUST COVER | Oct 11, 1979 | Substantially Equivalent |
| K790993 | INSTANT HOT & COLD PACKS | Sep 7, 1979 | Substantially Equivalent |
| K790644 | SUBMAX | Apr 26, 1979 | Substantially Equivalent |
| K780033 | MATTRESSES, CONDUCTIVE & COVERS | Feb 21, 1978 | Substantially Equivalent |
| K771792 | ENEMA SET | Oct 20, 1977 | Substantially Equivalent |
| K771791 | NEEDLE COUNTING | Oct 4, 1977 | Substantially Equivalent |
| K770898 | FRACTURE CAST BRACE KIT, PLASTIC | Jul 21, 1977 | Substantially Equivalent |
| K770899 | FRACTURE CAST BRACE, POLY | Jul 21, 1977 | Substantially Equivalent |
| K770173 | STOCKINETTE | Feb 8, 1977 | Substantially Equivalent |